Quality at Graviti is not a requirement to satisfy — it is the foundation everything else is built on, from raw material selection to final product release.
Beyond compliance
A zero-defect mindset
100% visual inspection
We manufacture pharmaceuticals that meet the highest global regulatory standards, ensuring safety, efficacy and reliability in every product. Our quality-driven culture is embedded in every stage of operations and guided by a continuous improvement approach.
USFDA, WHO-GMP and global regulatory compliance
End-to-end quality control and real-time monitoring
Strict adherence to cGMP and Quality by Design principles
Audit success
0
483 observations
USFDA inspection, 2023
Regulatory excellence, evidenced
Quality isn't just a benchmark for us; it's the core of everything we do. Our regulatory inspection in 2023 resulted in zero 483 observations, reinforcing our commitment to compliance, operational excellence and global best practice. It reflects a dedication to producing pharmaceuticals that meet the most stringent regulatory requirements — and a system designed to stay inspection-ready every day of the year, not just the week before.
Inspection-ready, every day
True precision
Quality by Design
We build quality into the product from the ground up, rather than testing for it at the end. Every process is meticulously designed, characterised and controlled.
01
Process Understanding & Risk Assessment
Identifying and controlling critical process parameters before they can become variables.
02
Robust Manufacturing Controls
Ensuring consistency in product performance and safety, batch after batch.
03
Continuous Process Validation
Real-time monitoring feeding a continuous loop of process optimisation.
04
Regulatory-Driven Development
Aligned with ICH, USFDA and EMA guidelines from the first formulation trial.
Our science-based, data-driven quality approach allows us to consistently deliver world-class pharmaceuticals.
Every batch tested, every result attributable.
Graviti is committed to providing safe, effective and reliable pharmaceuticals by adhering to the highest quality standards and global regulatory requirements.
To meet this commitment, Graviti fosters a quality-focused culture that emphasises premium quality products, regulatory compliance, data governance, customer satisfaction and continuous improvement.
Zero-touch data capture
Data integrity
Trust and transparency, on the record
Data integrity sits at the heart of regulatory compliance and patient safety. We maintain end-to-end data governance protecting the reliability and accuracy of every record.
Electronic batch records and secure audit trails
LIMS and Empower software for data management
21 CFR Part 11 compliance for electronic data integrity
Strict change control and documentation review processes
By eliminating data vulnerabilities and maintaining real-time records, we reinforce transparency, reliability and trust in our pharmaceutical processes.
Technology enhanced compliance
Nucleus — our centre for excellence
Nucleus is Graviti's Quality & Compliance Hub, uniting advanced analytics, regulatory intelligence and compliance expertise.
Nucleus in use
Mobile-first and paperless
A platform designed for the shop floor, not the filing cabinet — records captured where the work happens.
Integrated digital systems
Quality, manufacturing and laboratory systems speak to one another, removing transcription risk entirely.
Continuous enhancement
Ongoing automation and data acquisition improvements drive precision, efficiency and intelligence.
Safety driven
Safety for our people, our products and our environment
Through rigorous safety audits, training and preventive measures, we maintain a secure and compliant working environment.
Safe by design
01
Zero-Compromise Approach
Strict SOPs and layered risk mitigation measures across every operation.
02
Controlled Environments
Temperature, humidity and contamination control held continuously in specification.
03
Workplace Safety & EHS
Aligned with OSHA and GMP safety protocols, audited and trained on repeatedly.
04
Predictive Maintenance
Preventive programmes that keep equipment reliable and operations safe.
Evolving excellence
Continuous improvement, top down
Quality systems are embedded into our mission and long-term strategy, not bolted on as a compliance exercise.
01
Planning
Establishing control procedures, allocating resources, and ensuring thorough documentation and communication for seamless execution.
02
Design
Developing robust systems that offer clear guidance and enable ongoing evaluation to maintain excellence.
03
Review
Internal audits and management reviews, followed by corrective and preventive actions that close gaps and drive improvement.
Digital batch review
Automated sampling
Quality review board
Empowering excellence with every step
Self Inspection
Regular, structured self-inspections keep processes, facilities and operations aligned with the highest regulatory standards — identifying gaps before they become issues and maintaining a state of constant audit readiness.
Supplier Management
Qualification, audit and continuous performance review of every material source, so quality begins upstream of our own walls.
Maintenance
Predictive and preventive programmes that keep qualified equipment in a validated state throughout its lifecycle.
Change Management
Formal impact assessment and approval for every change, with traceability from proposal through to verification.
Validation
Process, cleaning and hold-time validation studies that prove performance rather than assume it.
Documentation Management
Controlled, reviewable, reconstructable records — the evidence base behind every batch we release.
